SIST EN ISO 8536-1:2008

Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2006)

This part of ISO 8536 specifies the dimensions, performance and requirements of infusion glass bottles necessary to ensure functional interchangeability. It is applicable only to infusion bottles for single use.

Infusionsgeräte zur medizinischen Verwendung - Teil 1: Infusionsflaschen aus Glas (ISO 8536-1:2006)

Dieser Teil von ISO 8536-1 legt Maße, Ausführungen und Anforderungen für Infusionsflaschen aus Glas fest, die erforderlich sind, um die funktionelle Austauschbarkeit sicherzustellen. Er gilt nur für Infusionsflaschen zur einmaligen Verwendung.

Matériel de perfusion à usage médical - Partie 1: Flacons en verre pour perfusion (ISO 8536-1:2006)

L'ISO 8536-1:2006 sp�cifie les dimensions, la performance et les exigences relatives aux flacons en verre pour perfusion afin d'assurer leur interchangeabilit�. Elle n'est applicable qu'aux flacons en verre pour perfusion non r�utilisables.

Infuzijska oprema za uporabo v medicini - 1. del: Infuzijske steklenice (ISO 8536-1:2006)

General Information

• Status: Withdrawn
• Publication Date: 03-Jun-2008
• Withdrawal Date: 08-Nov-2011
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 08-Nov-2011
• Due Date: 01-Dec-2011
• Completion Date: 09-Nov-2011
• Ref Project: EN ISO 8536-1:2008 - Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2006)

Relations

• Replaces: SIST EN ISO 8536-1:2003/AC:2005 - Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2000)
• Effective Date: 01-Jul-2008
• Replaces: SIST EN ISO 8536-1:2003 - Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2000)
• Effective Date: 01-Jul-2008
• Revised: SIST EN ISO 8536-1:2011 - Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2011)
• Effective Date: 01-Dec-2011

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2006)Infuzijska oprema za uporabo v medicini - 1. del: Infuzijske steklenice (ISO 8536-1:2006)Matériel de perfusion à usage médical - Partie 1: Flacons en verre pour perfusion (ISO 8536-1:2006)Infusionsgeräte zur medizinischen Verwendung - Teil 1: Infusionsflaschen aus Glas (ISO 8536-1:2006)11.040.20Transfuzijska, infuzijska in injekcijska opremaTransfusion, infusion and injection equipmentICS:SIST EN ISO 8536-1:2008enTa slovenski standard je istoveten z:EN ISO 8536-1:200801-julij-2008SIST EN ISO 8536-1:2008SLOVENSKI
STANDARDSIST EN ISO 8536-1:2003/AC:2005SIST EN ISO 8536-1:20031DGRPHãþD







EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 8536-1March 2008ICS 11.040.20Supersedes EN ISO 8536-1:2003
English VersionInfusion equipment for medical use - Part 1: Infusion glassbottles (ISO 8536-1:2006)Matériel de perfusion à usage médical - Partie 1: Flaconsen verre pour perfusion (ISO 8536-1:2006)Infusionsgeräte zur medizinischen Verwendung - Teil 1:Infusionsflaschen aus Glas (ISO 8536-1:2006)This European Standard was approved by CEN on 7 March 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 8536-1:2008: E



EN ISO 8536-1:2008 (E) 2 Contents Page Foreword.3



EN ISO 8536-1:2008 (E) 3 Foreword The text of ISO 8536-1:2006 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 8536-1:2008 by Technical Committee CEN/SS S02 “Transfusion equipment” the secretariat of which is held by CMC. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2008, and conflicting national standards shall be withdrawn at the latest by September 2008. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 8536-1:2003. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 8536-1:2006 has been approved by CEN as a EN ISO 8536-1:2008 without any modification.







Reference numberISO 8536-1:2006(E)© ISO 2006
INTERNATIONAL STANDARD ISO8536-1Third edition2006-03-15Infusion equipment for medical use — Part 1: Infusion glass bottles Matériel de perfusion à usage médical — Partie 1: Flacons en verre pour perfusion



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ISO 8536-1:2006(E) © ISO 2006 – All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 8536-1 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. This third edition cancels and replaces the second edition (ISO 8536-1:2000) and amendment ISO 8536-1:2000/Amd.1:2004, of which it constitutes a minor revision. ISO 8536 consists of the following parts, under the general title Infusion equipment for medical use: ⎯ Part 1: Infusion glass bottles ⎯ Part 2: Closures for infusion bottles ⎯ Part 3: Aluminium caps for infusion bottles ⎯ Part 4: Infusion sets for single use, gravity feed ⎯ Part 5: Burette infusion sets for single use, gravity feed ⎯ Part 6: Freeze drying closures for infusion bottles ⎯ Part 7: Caps made of aluminium-plastics combinations for infusion bottles ⎯ Part 8: Infusion equipment for use with pressure infusion apparatus ⎯ Part 9: Fluid lines for use with pressure infusion equipment ⎯ Part 10: Accessories for fluid lines for use with pressure infusion equipment ⎯ Part 11: Infusion filters for use with pressure infusion equipment ⎯ Part 12: Check valves



ISO 8536-1:2006(E) iv © ISO 2006 – All rights reserved Introduction Infusion bottles are suitable primary packaging materials for the storage of infusion solutions until they are administered to the patient. Due to the direct contact between infusion solution and the primary container components and in view of the extended storage periods, possible interactions must be avoided in order to guarantee the patient's safety. Adequate means to achieve this goal include the proper selection of the primary packaging materials, the choice of suitable package design and the availability of specific criteria and methods for testing of individual container systems.



INTERNATIONAL STANDARD ISO 8536-1:2006(E) © ISO 2
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